Compliance Resources to Help you Stay Current

On September 14, the FDA announced that it was creating a new, streamlined and integrated system to effectively and rapidly respond to human and animal foodborne illness outbreaks. The agency has named the system as the FDA Coordinated Outbreak Response and Evaluation (CORE) Network.

This article gives details about this new FDA initiative.

On August 16, 2011, the FDA issued draft guidance for the medical device industry and its own staff on how to conduct postmarket surveillance. This new guidance, when it is finalized, is expected to supersede the guidelines issued in 2006.

This article gives an overview of the new guidance and recommendations.

The FDA will soon be implementing a new import screening tool, Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting or PREDICT. This system is expected to improve the current electronic screening system by targeting higher risk products and minimizing delays in shipping lower risk products.

This article gives a brief overview of the PREDICT tool and recent developments in its implementation.

The IEC 62304 is a global harmonized standard adopted by the US and EU. It gives life cycle requirements for medical device software as well as medical software.

This article gives an overview of the standard and a summary of the IEC 62304 requirements for software development.

The FDA released draft guidance in May 2011 to assist clinical investigators, industry and FDA staff in interpreting and complying with regulations governing financial disclosures by clinical investigators, 21 CFR Part 54.

This article gives an overview of the recommendations included in the draft guidance. Comments on these draft guidelines were due by July 25, 2011.

As medical devices become increasingly available for home use and more use-accessible and friendly, it has become important for manufacturers to ensure the product’s quality, safety and reliability. Medical device quality regulatory requirements issued and enforced by agencies such as the FDA act as a valuable guide for manufacturers.

This article gives a brief overview of the FDA’s medical device quality system regulations.

Following good laboratory practices (GLPs) is necessary to ensure that quality is maintained and results are accurate. In this article, Marcelle Cortezia, an expert on pharma manufacturing and quality processes, gives practical tips on the following GLP areas:

• General Laboratory Practices and Test Procedures
• Laboratory Documentation
• Laboratory Training and Personnel Certification

In this article, Marcelle Cortezia, an expert on pharma manufacturing and quality processes, discusses the best ways to conduct cleaning test method validation. Marcelle discusses the various steps involved and different regulatory recommendations for this essential process in the manufacture of drug products.

This article establishes a rationale to justify the level and extension of Environmental Monitoring to be applied at non-sterile pharma facilities based on the risk compound by  factors such as location and product susceptibility to microbial contamination.

The author, Marcelle Cortezia, has ten years of experience with major pharmaceutical companies and is at present a Quality Manager with Dentsply.

Google has agreed to pay $500 million dollars as a settlement in a Department of Justice inquiry into whether the search engine’s advertisements for online Canadian pharmacies led to illegal imports of prescription drugs.

This article gives details of the allegations against Google and the regulatory violations that led to the inquiry.

The FDA has for the first time issued a draft guidance clarifying how benefit-risk determinations are made during premarket review of certain medical devices. The recommendations made in the guidance are intended to improve the predictability, consistency and transparency of the premarket review process for applicable devices, and should help manufacturers navigate the approval process more easily. The agency is presently accepting comments on these draft guidelines.

This article provides a summary of the guidance document’s recommendations.

The Institute of Medicine has released a report that has found the FDA’s existing rules for the 510(k) clearance lacks the legal basis to be a reliable premarket screen of the safety and effectiveness.

The report has been criticized by the medical device industry while patient rights groups have welcomed its findings.

In this article, Dev Raheja, a renowned expert on Medical Devices, their software and regulatory requirements, discusses how to write effective software for medical devices, the risks, requirements and specifications.

An ePedigree or electronic pedigree is an electronic document that satisfies pedigree requirements of prescription drugs. While the FDA hasn’t implemented ePedigree specific regulations for the pharmaceutical supply chain, California has formulated laws regarding the use of ePedigrees.

This article describes the background to ePedigrees, current regulations governing their use and implementation status.

In October 2009 the Federal Trade Commission (FTC) released its final Guides Concerning the Use of Endorsements and Testimonials in Advertising. The Guides revise the FTC's initial guidelines published in 1980, providing advertisers and spokespeople with insight on how to keep their endorsement and testimonial advertisements in compliance with the FTC Act, particularly in light of new issues posed by the emergence of social media. The Guides took effect on December 1, 2009.

This article gives the background to the Guides and provides a summary of the guidelines.

South Korean medical device manufacturer Sometech Inc. has been sent a warning letter by the FDA on April 6, 2011, for inadequate, non-compliant CAPA, customer complaint handling and design documentation procedures, among other violations.

More than three decades after sunscreen labeling requirements were first introduced, the FDA announced these updates that will boost its efforts to ensure that sunscreens “meet modern-day standards for safety and effectiveness”. The previous labeling used in OTC sunscreens dealt almost exclusively with protection against sunburns caused primarily by ultraviolet B (UVB) radiation from the sun. The labels did not address the more dangerous ultraviolet A (UVA) radiation which contributes to skin cancer and early skin ageing.

Warning letter sent to Jilin Shulan Synthetic Pharmaceutical Co. regarding significant deviations from Current Good Manufacturing Practice (CGMP) for the manufacture of APIs.

The US Food & Drug Administration (FDA) announced on Jan 20, 2011 that the following have signed a consent decree:

• Portland Shellfish Co.
• Jeffrey D. Holden, company president
• Satyavan Singh, quality manager
• John A. Maloney, general manager

The consent decree prohibits them from distributing seafood in interstate commerce until the FDA has approved in writing Portland’s Hazard Analysis and Critical Control Point (HACCP) plans, sanitation program and Listeria monocytogenes (L. mono) testing program.

The violation

The Portland, Maine-based seafood processor sells ready-to-eat lobster, shrimp and crab products to retailers in Massachusetts, California, Georgia, Illinois, Nevada, Washington, New Jersey and Louisiana. Portland Shellfish violated the Federal Food, Drug & Cosmetic Act by introducing into interstate commerce, food that was prepared, packed or held under insanitary conditions.

FDA investigators documented significant deviations from the seafood HACCP regulation. The FDA’s laboratory analysis of samples collected by investigators during the company’s 2010 inspection confirmed the presence of L. mono within a Portland Shellfish food processing facility and in a ready-to-eat product. L. mono is a pathogenic bacterium that, when ingested, can cause the disease listeriosis.

Previous FDA inspections documented insanitary conditions at Portland Shellfish’s facilities and ongoing violations of applicable regulations. Despite the FDA’s warnings Portland Shellfish Co., Inc. continued to violate FDA regulations and the Act. The decree also allows the FDA to order a shutdown, recall or other corrective action in the event of future violations. Failure to abide by the agreement can also lead to civil or criminal penalties.

Regulations

The FDA enforces the seafood HACCP regulation to ensure the safety of fish and fishery products distributed to the public. Failure to comply with the seafood HACCP regulation renders food adulterated under the Act.

Source:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm239108.htm

FDA regulates medical devices and places them under one of the three classes, viz., Class I, Class II and Class III, based on the level of risk they carry. Class I and Class II devices are generally regarded as low-risk devices. They require FDA Clearance of an application called Premarket Notification ((or 510(k)) if the device is to be permitted to be sold in US. Class III devices, which tend to be high-risk devices and first-of-a-kind devices, require FDA Approval in the form of a Premarket Approval (PMA) Application.